- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology… more
- UTMB Health (Gatesville, TX)
- Regional Medical Director , CMC **Gatesville, Texas, United States** Physician UTMB Health Requisition # 2500313 The mission of Correctional Managed Care is to ... responsibility for all medical providers assigned within the region. Works under the director of the senior medical director . **_ESSENTIAL JOB FUNCTIONS_**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory ** **Science** **KEY** ... **RESPONSIBILITIES** The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Lilly (Indianapolis, IN)
- …wage for this position is $162,000 - $237,600 **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
- Sumitomo Pharma (Springfield, IL)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects.… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... for employees to grow and develop their skills. The Director , Regulatory Affairs will be responsible for...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Senior Director , Clinical Development ... Senior Director Clinical Development - Respiratory...working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical and pre-clinical… more
- AbbVie (North Chicago, IL)
- …with internal and external stakeholders. + Stay updated on global CMC technical, regulatory , compliance developments, and industry practices. Qualifications ... Facebook, Instagram, YouTube and LinkedIn. Job Description As an Associate Director , Operations Strategy and Pipeline Leadership (OSPL) within the Product… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader** **Foster City, CA** **KEY ... in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
- Hartford HealthCare (Southington, CT)
- …Center* **Title:** * Senior Director of Clinical Services, Senior Services* **Location:** *Connecticut-Southington-80 Meriden Ave Southington CMC (10209)* ... we offer premier physical, occupational and speech therapies. Position Summary: The Senior Director of Clinical Services will provide leadership and clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- … affairs organization. The incumbent will collaborate with patient safety, quality, regulatory CMC , commercial, clinical, and other development organizations on ... create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of safe life-changing therapies. **Job Summary:** Gilead Sciences is currently seeking a Senior Director level position to be the leader of Packaging Quality ... leaders in in Portfolio Strategy team, Manufacturing, Packaging, Supply Chain, Regulatory CMC , and the wider PDM Quality organization to achieve business… more
- Bristol Myers Squibb (San Diego, CA)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Senior Director - Clinical Pharmacology will be a key member of the ... with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals. + Collaborate with DMPK, clinical development,… more
- AbbVie (Irvine, CA)
- …Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we ... experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability… more
- Merck (West Point, PA)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust ... regulatory posture + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in safety and environmental… more
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